Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite

Proximal humerus is a common site for primary bone tumors and metastatic disease. Reconstruction with reverse shoulder arthroplasty (RSA) after resection is a surgical challenge and presented high risk of complication. The options for reconstruction after proximal humerus tumor resection are limited, and depend on the soft tissue conditions and bone loss. The most commonly used techniques include long cemented stem alone (in case of limited resection), allograft prosthetic composite (APC), massive prosthesis. In some cases two step procedure are performed : first step is resection and RSA with cement sleeve, and second step is APC or massive prosthesis.

Study Overview

• Status: Enrolling by invitation
• Conditions: Shoulder Disease
• Intervention / Treatment: Procedure: reverse shoulder arthroplasty

Detailed Description

Theses surgical options are complex, technically challenging, and at risk of complications (dislocation, infections, allograft pseudarthrosis…). High complication rate, length of the surgical procedure and post-operative recovery are a concern for theses frail patients.

Timing before being able to schedule the intervention (selection of the appropriately sized allograft, restricted access to grafts…) is also an issue. Postponing cancer resection surgery increases the risk of both local and distant tumor invasion. In case of secondary bone tumors, surgery is often decided for pain relief rather than with a curative intent. In cases where rapid bone graft is not available, and urgent surgery is required for pain or for oncological reasons, the bone loss can be compensated for by a temporary cement sleeve . In some cases, either because life expectancy has improved or has been longer than anticipated, or because the patient declined a second surgery for the implantation of an allograft, some patients can stay with the reconstruction with a long-cemented stem and cement sleeve.

The objective of this study was to compare functional outcomes and complications between APC and cement sleeve reconstruction. Our hypothesis was that, in cases of proximal humerus resection for tumors, reverse prostheses included in cryopreserved allografts would yield better clinical results and greater longevity than suspended prostheses with proximal metaphyseal reconstruction using a cement sleeve.

• Study Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • CHRU - Centre chirurgical emile galle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients treated for tumors of proximal humerus, who underwent a Malawer type I resection of this tumors

Description

Inclusion Criteria:

• tumors of proximal humerus
• Malawer type I resection of this tumors
• primary reconstruction

Exclusion Criteria:

• resection and reconstruction by prosthesis alone
• resection and hemiarthroplasty reconstruction
• resection and revision protheses.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
allograft prosthetic composite; patients treated with resection and reconstruction with reverse prostheses included in cryopreserved allografts	Procedure: reverse shoulder arthroplasty; resection of proximal humeral tumors and reconstruction with reverse shoulder arthroplasty
cement sleeve; patients treated with resection and reconstruction with suspended prostheses with proximal metaphyseal reconstruction using a cement sleeve	Procedure: reverse shoulder arthroplasty; resection of proximal humeral tumors and reconstruction with reverse shoulder arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant score	Shoulder functional evaluation score : between 6 points ( worse outcome) and 100 points (better outcome)	through clinical completion an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication	dislocation, infection,	through clinical completion an average of 5 years
mortality	death: intervention-related or non-intervention-related, cause of death, delay of death	through clinical completion an average of 5 years
revision	reoperation (with or without implant extraction), cause of revision, delay of revision	through clinical completion an average of 5 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Chair: Francois SIRVEAUX, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: shoulder arthroplasty; reverse shoulder arthroplasty; allograft prosthetic composite
• Other Study ID Numbers: 2024PI057

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No